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Stress Related DisorderPhase 4AdjuvantNCT03600493

Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries

A Phase 4 study testing Dexmedetomidine and Lidocaine in people with Stress Related Disorder, run by Suez Canal University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Stress Related Disorder
What is being tested?
Dexmedetomidine and Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
Aug 2018to Jul 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both gender.
  • Consent from patients about technique and nature of the study.
  • Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II).
  • Patients scheduled for major abdominal surgery.

Who cannot join

  • Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease
  • Known allergy to Dexmedetomidine or Lidocaine.
  • History of endocrine disorders.
  • Heart block greater than first degree.
  • Medication known to affect the sympathetic response or hormonal secretion.
  • Smokers.

Trial locations and contacts

No sites are listed yet.

Mohamed A Elsadany, MD contact

00966541738161

Sadany20@gmail.com

About this study

Official title: Comparison Between Dexmedetomidine and Lidocaine as an Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries

assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia

Read the detailed description

Methodolgy

During the preoperative visit, the techniques will be explained to patients including benefits and complications.

  1. Pre-operative assessment:
  2. Medical history:
  3. Medical disorders as hypertension, diabetes, heart, chest, liver or kidney diseases.
  4. Past history of operations, hospitalization or blood transfusion.
  5. Past anesthetic history with impact on previous airway problems during previous surgeries, hypersensitivity to anesthetic medications, any previous post-operative complications that could be attributed to anesthesia.
  6. Family history for specific anesthetic problems like malignant hyperthermia.
  7. Physical examination:
  8. General examination, \& vital signs (heart rate, blood pressure, respiratory rate and temperature) in bed the night before operation
  9. Heart, chest and abdominal examinations
  10. Anesthetic assessment:
  11. Examination of the limbs for prediction of difficult cannulation.
  12. Airway assessment including:
  13. Thyromental distance
  14. Mallampatti score
  15. Neck and tempro-mandibular joint mobility
  16. Assessing the absence of deformities in the mandible, face, tongue, palate, teeth and neck that may interfere with airway management
  17. Laboratory investigations:
  • Complete blood count
  • Prothrombin time and partial tissue thromboplastic time
  • Kidney function test (s, creatinine \& urea), Liver function test (ALT, AST, albumin and bilirubin) \& Random blood sugar.
  • Serum Cortisol and IL6 level before starting drug infusion.
  1. Demographic data: The patient's age, sex, ASA status, and duration of surgery will be recorded.
  2. Technique:
  3. Patients will be fasting for 6 - 8 hours.
  4. All patients will receive oral midazolam (7.5 mg), and oral ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
  5. All patients will receive a pre-induction normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
  6. All operations will start between 08.30 am and 09.30 am, to minimize variations in cortisol level.
  7. All patients will receive the drug of study 10 min before induction of anesthesia till the start of wound closure in the form of: Group (D) Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the end of wound closure. Group (L) Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr.
  8. Doses will be calculated, diluted in 50 ml of normal saline and given intravenously by a syringe pump over 10 minutes initially and then over 1hr till the start of wound closure.
  9. All drugs of the study will be prepared by an independent anesthesiologist who will not share in the study and then selected and given by another one blinded for the content of each syringe.
  10. Airway devices, anesthesia machine, ventilator, flowmeters and monitors will be checked promptly.
  11. Another wide-bore I.V cannula will be inserted in case of blood transfusion.
  12. Monitoring equipment's (Datex-Ohmeda™) will be attached to the patient including 3-leads ECG, non-invasive arterial blood pressure, pulse oximetery and capnograph after tracheal intubation.
  13. The depth of anesthesia will be monitored with Entropy device. The Entropy electrodes will be placed on the forehead and on the lateral angle of orbit and connected to (Datex-Ohmeda™) by a special. The target Entropy range will be 40-60 for surgical anesthesia.
  14. Induction of anesthesia will be performed by Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg and fentanyl 1 mcg/kg given intravenously after pre-oxygenation with 100% oxygen for at least 3 minutes.
  15. Patients will be manually ventilated with 100% oxygen till intubation after 2 min and with Entropy value of 60 to 40 by Macintosh laryngoscope and appropriate size endotracheal tube.
  16. Maintenance of anesthesia will be carried out by isoflurane varying its end tidal concentration to keep Entropy in the range of 55 to 40 with Air:Oxygen mixture 0.3 fraction of oxygen and flow rate of 2 liter in completely closed circuit.
  17. Cis-atracurium 0.03 mg/kg guided by neuromuscular monitor Train of Four (TOF) will be used for muscle relaxation.
  18. Hemodynamics (mean arterial blood pressure and heart rate) will be maintained within 25 % of baseline measures.
  19. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2-3 min will be managed by I.V bolus of fentanyl 0.5 mcg/kg and any decrease of MAP or HR less than 25 % on two consecutive readings within 2-3 min will be managed by I.V bolus of ephedrine 5 mg or atropine 0.5 mg respectively.
  20. The infusion of study medication will be discontinued if the hypotension persisted > 5 min after these interventions upon return of the MAP or HR to within 25% of the baseline value, the study medication infusion will be resumed at 50% of the initial infusion rate and then gradually increased to the initial infusion rate.
  21. The infusion of study medication will be discontinued at the start of wound closure. Upon completion of wound closure, isoflurane will be discontinued and the inspired oxygen flow rate will be increased to 5 L/min and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. The trachea will be extubated when the patient is fully awake. Transfer to the recovery room will be done when the patient scored 7 and above using the modified Aldrete scoring system.
  22. On emergence from anesthesia and immediately in post anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h), will be used in all groups.
  23. The whole technique and anesthetic procedures will be performed by the same anesthesiologist to avoid as much as possible the inter-individual skill variations.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Selective Alpha 2 agonist

    Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.

  • LidocaineDrug

    Also called Lignocaine

    Lidocaine given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.

Study groups in NCT03600493
Study groupRoleWhat they receive
DexemetomidineActive comparatorDexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.
Receives: Drug: Dexmedetomidine
LidocaineActive comparatorLidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.
Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Serum Interleukin 6 (IL6)

    Serum Interleukin 6 will be measured in picogram/Milliliter

    Measured: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative

Secondary outcomes (7)
  1. Change in Serum Cortisol

    Measurement of Serum Cortisol levels in microgram/deciliter

    Measured: Serum Cortisol will be measured as baseline and then 2 hours after induction of surgery and then 6 hours postoperative

  2. Changes in Mean Arterial Blood Pressure (MABP)

    MABP changes in mmHg with intubation, extubation and throughout surgery

    Measured: Baseline MABP, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation

  3. Changes in Heart Rate (HR)

    HR changes with intubation, extubation and throughout surgery

    Measured: Baseline HR, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation

  4. Morphine consumption

    Total postoperative morphine consumption in mg during first 24 hours

    Measured: Morphine consumption during first 24 hours postoperatively

  5. Ephedrine

    Total Ephedrine dose in mg used intraoperative for treatment of hypotension

    Measured: During intraoperative period

  6. Atropine consumption using questionnaire

    Total Atropine dose in mg used intraoperative for treatment of bradycardia

    Measured: During intraoperative period

  7. Visual analogue scale VAS

    Pain scale measurement for postoperative assessment of pain consisting from 0 to 10 representing 0 as no pain and 10 as the most imaginable pain treating the patient if VAS > 3

    Measured: VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study startAug 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03600493
Sponsor's protocol ID
3399
Acronym
Adjuvant
Status last verified
Aug 2018
First submitted
2 Jul 2018
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Lidocaine in people with Stress Related Disorder, run by Suez Canal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed A Elsadany, MD (00966541738161, Sadany20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Interleukin 6 (IL6) (time frame: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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